Patient-Reported Outcomes (PROS) With Ramucirumab Versus Placebo in Chinese Patients With Hepatocellular Carcinoma (HCC) and Elevated Alpha-Fetoprotein From the Randomized Phase 3 Reach-2 Study
Author(s)
Chen X1, Shao G2, Bai Y3, Gu S4, Gu K5, Zhang Q6, Zhang W6, Liu J7, Zhou L6, Qin S8
1Department of Intervention Therapy, Guangdong Provincial People’s Hospital, Guangzhou, China, Guangzhou, China, 2Department of Radiology, Zhejiang Cancer Hospital, Hangzhou, China, Hangzhou, China, 3Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China, Harbin, China, 4Department of Interventional Radiology, Hunan Cancer Hospital, Changsha, China, Changsha, China, 5Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China, Hefei, China, 6Eli Lilly and Company, Shanghai, China, 7Eli Lilly and Company, Shanghai, 31, China, 8Cancer Center of Jinling Hospital, Nanjing University of Chinese Medicine, Nanjing, China
OBJECTIVES: In phase 3 REACH-2 study, ramucirumab demonstrated meaningful survival benefit with tolerability as second-line treatment in Chinese patients with advanced HCC and elevated AFP. PROs were evaluated in Chinese patients from REACH-2.
METHODS: Patients with ECOG PS 0/1, AFP ≥400 ng/mL and prior sorafenib were randomized 2:1 to receive ramucirumab 8 mg/kg or placebo biweekly. Patient-reported disease-related symptoms and health-related quality of life (QoL) were assessed by the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8) and EQ-5D-5L at baseline, every 6 weeks, and end of treatment. Time to deterioration (TTD) (≥3-point decrease in FHSI-8 total score or a decrease in one categorical response for each individual item; ≥0.058-point decrease in EQ-5D-5L index score using Chinese-specific value sets, from randomization to the first date of deterioration) was determined using Kaplan-Meier methods, HRs and 95% CIs were estimated with the Cox proportional hazards model.
RESULTS: 70/34 patients in ramucirumab/placebo groups were included in PROs analysis. Compliance with two instruments was similar between groups at baseline (≥97.1%) and end of treatment (≥66.7%). On-treatment compliance was higher in ramucirumab group with rate of >80.0% at early assessments. Median TTD in FHSI-8 total score (4.2 vs 2.9 months, unstratified HR 0.731 [95% CI 0.385-1.387]), three out of eight FHSI-8 symptoms including nausea (15.3 vs 2.8, HR 0.630 [0.293-1.353]), pain (5.7 vs 1.6, HR 0.526 [0.275-1.006]), and back pain (7.0 vs 2.9, HR 0.705 [0.320-1.549]), and EQ-5D-5L index score (5.6 vs 2.9, HR 0.809 [0.377-1.736]) were numerically prolonged with ramucirumab vs placebo. Mean FHSI-8 total score and EQ-5D-5L index score were maintained during treatment in both groups, with scores decreased at the end of treatment.
CONCLUSIONS: Ramucirumab as a second-line treatment for Chinese patients with advanced HCC demonstrated promising benefit in delaying deterioration of disease-related symptoms with no detriment in QoL.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
CO14
Topic
Clinical Outcomes
Topic Subcategory
Clinician Reported Outcomes
Disease
SDC: Gastrointestinal Disorders